Visby Medical Advances Men's Health with New Test Submission
If cleared, Visby Medical's Men's Sexual Health Test will provide rapid PCR results for detecting Chlamydia and Gonorrhea from male urine samples in various clinical settings. This response meets a growing clinical demand while aligning with established medical guidelines, especially as sexually transmitted infections (STIs) present significant public health challenges.
Innovative Technology for Rapid Testing
Visby Medical™, a leader in medical diagnostics, has officially submitted its Men's Sexual Health Test to the U.S. Food and Drug Administration (FDA) for 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver. The test promises to deliver Polymerase Chain Reaction (PCR) results in under 30 minutes, making it a vital tool for both symptomatic and asymptomatic men.
Point-of-Care Convenience
This innovative test is a single-use, instrument-free Point of Care (POC) solution that requires no capital investment, maintenance, or refrigeration. The convenience of this product allows for seamless integration into urgent care centers, community health clinics, and physician offices. It utilizes the same proven technology behind the Visby Medical Sexual Health Test, which previously received 510(k) clearance and CLIA waiver for use in women's health.
Addressing Critical Healthcare Needs
"This submission marks a significant step forward in Visby Medical's comprehensive Sexual Health diagnostic portfolio, enhancing our efforts to combat STIs that currently affect 20 percent of the U.S. population," stated Dr. Gary Schoolnik, Chief Medical Officer at Visby Medical. The Men's Sexual Health Test is designed to tackle the challenge of men being lost to follow-up after testing by streamlining the testing-to-treatment process with PCR-level accuracy.
Expanding Diagnostic Capabilities
Beside the Men's Sexual Health Test, Visby Medical has also gained 510(k) clearance and CLIA waivers for its Visby Medical Respiratory Health Test, which detects influenza types A and B, as well as SARS-CoV-2 (COVID-19). Dr. Schoolnik emphasized the importance of their core PCR technology in effectively addressing complex health conditions and delivering rapid, accurate diagnoses where they're needed most.
About Visby Medical™
Founded in 2012, Visby Medical is redefining how infectious diseases are diagnosed by enabling both physicians and patients to conduct accurate testing for infections anytime, anywhere, with laboratory-grade precision. Their proprietary technology provides true PCR results in less than 30 minutes through the world's first single-use, instrument-free PCR tests that are easily portable. Currently, Visby Medical offers FDA-cleared tests for STIs available in both point-of-care environments and directly to consumers at home, along with tests for respiratory infections. The company is focused on expanding its range and enhancing accessibility in both at-home and point-of-care markets.
Frequently Asked Questions
What is the purpose of the Men's Sexual Health Test?
The Men's Sexual Health Test aims to provide quick and accurate detection of Chlamydia and Gonorrhea from urine samples, addressing a significant public health issue.
How quickly can results be obtained from this test?
Results from the Men's Sexual Health Test can be delivered in under 30 minutes, making it a rapid diagnostic option.
Where can this test be implemented?
This test is designed for use in various clinical settings including urgent care centers, community health clinics, and physician offices.
What technologies are used in the test?
The test utilizes Polymerase Chain Reaction (PCR) technology to enable fast and accurate detection of STIs.
What is the company's focus for future tests?
Visby Medical is actively working on expanding its diagnostics platform to include a wider range of tests for at-home and point-of-care applications.
